Recruiting

Observational Study

Sponsor:

Sensydia Corporation

Code:

NCT06149143

Conditions

Cardiac Disease

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

Cardiac Performance System (NSR)

Study Details

Brief summary:

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Conditions

Cardiac Disease

Study ID

NCT06149143

Start date

Oct 3, 2023

Status verified date

Apr, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ability to provide written informed consent
  • 22 years of age or older
  • Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

Exclusion Criteria:

  • Previous Heart Transplant
  • Presence of Left Ventricular Assist Device
  • Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
  • Surgical scars/wounds/bandages/ports at the site of sensor placement

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiac Function Monitoring

Subjects scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure.

Interventions

Cardiac Performance System (NSR)

Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function.

Primary outcome measure

  • Cardiac Performance System electronic data for Cardiac Output [ Time Frame: 10 minutes before cardiac catheterization procedure ]
  • Cardiac Performance System electronic data for Pulmonary Artery Pressure [ Time Frame: 10 minutes before cardiac catheterization procedure ]
  • Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure [ Time Frame: 10 minutes before cardiac catheterization procedure ]
  • Pulmonary Artery Catheter electronic data for Cardiac Output [ Time Frame: 60 minutes during cardiac catheterization procedure ]
  • Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure [ Time Frame: 60 minutes during cardiac catheterization procedure ]
  • Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure [ Time Frame: 60 minutes during cardiac catheterization procedure ]
  • Echocardiography electronic data for Ejection Fraction [ Time Frame: 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure ]

Central Contacts and Locations

Central contacts

Sensydia

6618774670info[@]sensydia.com

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

Sensydia Corporation

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sensydia Corporation on 2024-04-17.